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Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).
The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goldmann Applanation Tonometer | Active Comparator | Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm. |
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| ORA G3 and ic100 | Active Comparator | Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm. |
|
| Tono-Vera Tonometer | Experimental | Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOP with Goldmann Applanation Tonometer | Device | Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (>23 mmHg). |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers. | Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The Tono-Vera Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups. | Through study completion, approximately 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Data collection for two measurement modes. | Tono-Vera has two measurement modes: A 6-measurement mode & "Quick" measurement mode. The 6-measurement mode will be used during this study. It will be possible to post-process the results to determine the IOP value that would have been obtained using Quick mode. As such the sponsor will be able to ensure the accuracy of both measurement modes compared to Goldmann Tonometry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Tseng, MD, PhD | Department of Opthalmology, Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Duke University | Durham | North Carolina | 27705 | United States |
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All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
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| IOP with comparator ORA G3 and ic100 tonometers | Device | Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. |
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| IOP with Tono-Vera Tonometer | Device | Measurement of IOP with Tono-Vera Tonometer |
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| Through study completion, approximately 4 months. |
| Data collection for device calibration. | The study will collect data on a large number of patients over a wide range of IOP values. The sponsor may use the collected data in a post-hoc analysis to verify that the Tono-Vera Tonometer factory calibration is optimal. | Through study completion, approximately 4 months. |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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